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Clinical Trials/NCT00734929
NCT00734929CompletedPhase 4

A Comparison of the Combination of Aprepitant and Dexamethasone Versus the Combination of Ondansetron and Dexamethasone for the Prevention of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Craniotomy

Duke University1 site in 1 country115 target enrollmentStarted: September 2007Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
115
Locations
1
Primary Endpoint
Cumulative Incidence of Emesis
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

We hypothesize that the combination of aprepitant with dexamethasone will provide significantly improved prophylaxis against Postoperative nausea and vomiting compared with the combination of ondansetron and dexamethasone, in patients undergoing craniotomy under general anesthesia.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •A patient is eligible for inclusion in this study if all of the following criteria apply:
  • •Age: 18-75 years of age
  • •Surgery: craniotomy under general anesthesia.
  • •American Society of Anesthesiologists (ASA) Status: ASA: I, II, or III
  • •Language: Fluent in the English language
  • •Informed Consent: Written informed consent must be obtained.

Exclusion Criteria

  • •A patient will not be eligible for inclusion in this study if any one or more of the following criteria apply within thirty days of patient enrollment in this clinical trial:
  • •Medical: Any condition that may impair a patient's ability to complete any of the study assessments or confound interpretation of results.
  • •Hypersensitivity: Patient has a known immediate or delayed hypersensitivity reaction or known idiosyncrasy to any of the two study medications, ondansetron, or aprepitant.
  • •Other Drugs: Patients should not be taking medications with known antiemetic properties (phenothiazines, butyrophenones, antihistamines), nor should they receive metoclopramide, or other antiemetics preoperatively or 12 hours before the scheduled surgical procedure.
  • •Pregnant or lactating females: A pregnancy test will be performed within 24 hours of entering the study for females of childbearing potential.
  • •Substance Abuse: Clinically significant abuse of substances (alcohol, illicit or prescribed medications) such that the patient is unable to provide informed consent or reliably complete any of the study assessments.
  • •Psychiatric Disease: History of a psychiatric illness that may impair the patient's ability to provide informed consent or complete any of the study assessments.
  • •Nausea verbal rating score (VRS): A VRS nausea score > 3 (scale 0-10) in the preoperative holding area before pretreatment with the study medications.

Arms & Interventions

1

Experimental

Aprepitant 40 mg preoperatively + dexamethasone 10 mg after induction of anesthesia

Intervention: Aprepitant + Dexamethasone (Drug)

2

Active Comparator

Ondansetron 4 mg within 30 min of the end of surgery + Dexamethasone 10 mg after induction of anesthesia

Intervention: Ondansetron + Dexamethasone (Drug)

Outcomes

Primary Outcomes

Cumulative Incidence of Emesis

Time Frame: 48 h

Any vomiting or retching

Secondary Outcomes

  • Incidence of Nausea(Post operative procedure (OP) hours (0-2, 24, 48))
  • Incidence of Vomiting (Post OP)(Post OP (0 - 2 hours))
  • Incidence of Vomiting (24 Hours)(24 h)
  • Use of Rescue Antiemetics (Post OP)(Post OP (0 - 2 hours))
  • Use of Rescue Antiemetics (24 Hours)(24 h)
  • Use of Rescue Antiemetics (48 Hours)(48 hour)
  • Number of Participants With a Complete Response Rate(24 hours Post OP, 48 hours Post OP)
  • Average Nausea Score(Post OP hours 0-2, 24 h, 48 h)
  • Number of Vomiting Episodes(48 hours)
  • Time to First Vomiting(48 h)
  • Number of Participants Who Rated Their Satisfaction With Antiemetic Management as "Very Satisfied"(48 hour)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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